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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRapid fFN for the TLiIQ System, Fetal Fibronectin Enzyme Immunoassay
Generic NameENZYME IMMUNOASSAY, FETAL FIBRONECTIN
ApplicantHOLOGIC, INC.
1240 Elko Drive
Sunnyvale, CA 94089
PMA NumberP920048
Supplement NumberS013
Date Received01/02/2018
Decision Date01/28/2020
Product Code LKV 
Advisory Committee Toxicology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a new supplier of a critical component, A137 ascites, that is used in the manufacture of Rapid fFN for the TLiIQ System and Fetal Fibronectin Enzyme Immunoassay.
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